Important news for pharma companies: the Bolar exemption is about to be broadened

Before a medicinal product can be marketed in the UK, it must first be given regulatory approval following clinical tests to show that the product is safe and effective. Producers of generic medicines can use the original manufacturer’s approval provided they can show that the generic product is bioequivalent to the approved medicine. However, the generic producer may face an action for patent infringement if it conducts clinical trials on a patented product before the expiry of the patent. The Bolar exemption means that such clinical trials will not constitute patent infringement.

The exemption sits within two EU directives — the directive on medicinal products for human use and a directive on veterinary medicinal products — and the relevant provisions are transposed into English law by section 60(5) of the Patents Act 1977.

The government has been consulting on broadening the scope of the Bolar exemption and, to that end, the draft Legislative Reform (Patents) Order 2014 was laid before Parliament on 6 May 2014. Broadly, the draft order will extend the Bolar exemption to cover the conducting of necessary trials and health technology assessments of all drugs, both novel and generic, and all applications for marketing authorisations…

Click on the link below to read the rest of the Walker Morris briefing.

Sign in or Register to continue reading this article

Sign in


It's quick, easy and free!

It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.

Register now

Why register to The Lawyer


Industry insight

In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.


Market intelligence

Identify the major players and business opportunities within a particular region through our series of free, special reports.


Email newsletters

Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.

More relevant to you

To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.

Briefings from Walker Morris

View more briefings from Walker Morris

Analysis from The Lawyer

View more analysis from The Lawyer


Kings Court
12 King Street

Turnover (£m): 42.50
No. of lawyers: 188